High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: vitamin D3.
- Кому может быть актуально
- Состояния в реестре: Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency. Базовые параметры: 5 лет — 25 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
Обзор
The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.
Подробное описание
The investigators will be administering oral high dose interval vitamin D3 concurrently when participants with inflammatory bowel disease (IBD) are receiving biologic therapy every 4-8 weeks. The investigators will collect additional bloodwork when participants are getting clinical labwork in order to assess markers of bone health and inflammation in response to vitamin D treatment. The investigators will serially assess with questionnaires associated measures, including dietary vitamin D and calcium intake, sunlight exposure, physical activity, fracture history, IBD disease activity, and overall health.
Вмешательства
- Пищевая добавка vitamin D3
Subjects will receive oral high dose interval vitamin D3, concurrently when they are receiving their biologic treatment for their inflammatory bowel disease every 4-8 weeks.
Первичные конечные точки
- vitamin D target [Срок оценки: at study conclusion, up to 64 weeks]
Вторичные конечные точки (12)
- change in vitamin D level [Срок оценки: at study conclusion, up to 64 weeks]
- vitamin D binding protein [Срок оценки: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- parathyroid hormone [Срок оценки: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- serum safety parameter [Срок оценки: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- urine safety parameter [Срок оценки: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- bone mineral density [Срок оценки: at study conclusion, up to 64 weeks, when clinically available]
- markers of bone turnover [Срок оценки: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- inflammatory bowel disease treatment parameters [Срок оценки: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
- cytokine measurements [Срок оценки: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)]
- c-reactive protein [Срок оценки: at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available]
- erythrocyte sedimentation rate [Срок оценки: at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available]
- health-related quality of life questionnaire for inflammatory bowel disease [Срок оценки: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)]
Критерии участия
Критерии включения
- Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis
- Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks
- Age 5-25 years old, at study entry
- Measured serum level of 25-OHD of less than 40 ng/mL in the last 4-8 weeks and no changes in vitamin D supplementation in the interim. Of note, 25-OHD levels are evaluated routinely as part of standard clinical care for IBD
Критерии исключения
- History of any underlying kidney disease
- History of preexisting liver disease
- History of granulomatous disease
- Inability to take oral vitamin D3 as a pill
- History of hypercalcemia or hypercalciuria
- Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
США · 1 центр
- Boston Children's Hospital — Boston
Публикации
- Gordon RJ, Vishwanath V, Lavoie A, Mishra R, Rufo PA. Efficacy and Safety of Titrated High-Dose Cholecalciferol Supplementation in Children and Young Adult Patients with Inflammatory Bowel Disease. J Pediatr. 2026 Jul;294:115084. doi: 10.1016/j.jpeds.2026.115084. Epub 2026 Mar 30. PMID 41921771
Идентификаторы
NCT: NCT04331639 · P00033424